Status:

RECRUITING

Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma

Lead Sponsor:

Sanofi

Conditions:

Asthma

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

Brief Summary

This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma. The purpose of this study is to assess the efficacy, safety, and tolerability...

Eligibility Criteria

Inclusion Criteria:

  • Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINA guidelines.
  • At least 1 asthma exacerbation in the year prior to Screening (Visit 1).
  • Pre-BD FEV1 of equal or more than 40% of predicted normal (by Global Lung Function Initiative [GLI] standards) at Screening (Visit 1).

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Other severe lung diseases (eg, chronic obstructive pulmonary disease [COPD]. bronchiectasis, idiopathic pulmonary fibrosis, etc) which may impair lung function.
  • Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening (Visit 1) (counting from the date of completion of treatment for asthma exacerbation).
  • Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening (Visit 1).
  • Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
  • Evidence of any infection requiring systemic anti-infective treatment within 2 weeks before Screening (Visit 1) or during the screening period. Significant viral infections within 2 weeks before Screening (Visit 1) or during the screening period even if the participant has not received systemic antiviral treatment (eg, influenza receiving only symptomatic treatment).
  • Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active TB), or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1).
  • Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure, and pulmonary disease.

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical study.

Key Trial Info

Start Date :

November 7 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 15 2027

Estimated Enrollment :

1147 Patients enrolled

Trial Details

Trial ID

NCT06676319

Start Date

November 7 2024

End Date

October 15 2027

Last Update

April 16 2026

Active Locations (236)

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Page 1 of 59 (236 locations)

1

The Center for Clinical Trials - Saraland- Site Number : 8400096

Saraland, Alabama, United States, 36571

2

Chandler Clinical Research Trials- Site Number : 8400075

Chandler, Arizona, United States, 85224

3

Epic Medical Research - Sun City- Site Number : 8400052

Sun City, Arizona, United States, 85351

4

Tucson Clinical Research Institute- Site Number : 8400085

Tucson, Arizona, United States, 85712

Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma | DecenTrialz